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更新于：2026-11-10
Ecnoglutide
埃诺格鲁肽
更新于：2026-11-10
概要
基本信息
原研机构 |
非在研机构 |
最高研发阶段批准上市 |
首次获批日期 中国 (2026-01-27), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构/序列
Sequence Code 452883170
来源: *****
关联
28
项与 埃诺格鲁肽 相关的临床试验NCT07836270
A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Safety and Efficacy of Ecnoglutide Injection in Overweight or Obese Chinese Adolescents (SLIMMER-YOUNG)
NCT07734311
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Ecnoglutide Injection in Obese Participants With Knee Osteoarthritis (KOA)
NCT07628127
A Randomized, Double-blind, Placebo-controlled, First-in-Human Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral VRB-103 Alone or in Combination With Oral Ecnoglutide (VRB-101) in Participants With Obesity or Overweight
100 项与 埃诺格鲁肽 相关的临床结果
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100 项与 埃诺格鲁肽 相关的转化医学
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100 项与 埃诺格鲁肽 相关的专利（医药）
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30
项与 埃诺格鲁肽 相关的文献（医药）2026-10-01JOURNAL OF CHROMATOGRAPHY A
Development and validation of a multiplexed LC-HRMS method for nine GLP-1 receptor agonists and its pharmaceutical application
Article
作者: Hung, Chi-Tat ; Leung, King-Kwong ; Tong, Lok-Hang
A rapid, sensitive, and selective multiplexed liquid chromatography-high-resolution mass spectrometry (LC-HRMS) method was developed and validated for the identification and quantitation of nine structurally diverse peptide-based glucagon-like peptide-1 receptor agonists (GLP-1 RAs): bofanglutide, ecnoglutide, exenatide, liraglutide, mazdutide, retatrutide, semaglutide, survodutide, and tirzepatide. These peptides represent single, dual, and triple receptor agonists, including four globally approved medications, two recently approved by China's National Medical Products Administration (NMPA), and three investigational drugs in Phase III clinical trials. Chromatographic separation was achieved on an ACQUITY Premier BEH C18 column (2.1 × 150 mm, 1.7 µm) at 50 °C using a multistep linear gradient with water and acetonitrile containing 0.1% difluoroacetic acid (DFA) and 0.5% dimethyl sulfoxide (DMSO) as mobile phases (flow rate 0.3 mL/min). The optimised method provided excellent resolution with baseline separation for most peptides within a 20-minute runtime. A key advantage of this work is the implementation of a dual strategy that combines high-resolution full-scan MS (HRMS) for accurate mass measurement with data-dependent HRMS/MS fragmentation for structural confirmation. Peptide identification adopted a top-down approach, achieving mass accuracy of 0.0-0.5 ppm and fragment ion coverage of 76-100%. The method showed good linearity (r² ≥ 0.995) over 4-235 ng/mL, with LODs of 0.44-2.06 ng/mL and LOQs of 8.29-11.74 ng/mL. It was successfully applied to marketed formulations of liraglutide, semaglutide, and tirzepatide using a simple dilute-and-shoot procedure, yielding mean recoveries of 113.7-118.4%. This LC-HRMS method offers superior selectivity and flexibility for analysing current and next-generation GLP-1 RAs.
2026-09-01DRUGS
Ecnoglutide: First Approvals
Review
作者: Shirley, Matt
Ecnoglutide is a cyclic adenosine monophosphate (cAMP)-biased glucagon-like peptide-1 (GLP-1) receptor agonist being developed by Sciwind Biosciences for the treatment of type 2 diabetes mellitus (T2DM) and for use in long-term weight management. In January 2026, subcutaneous ecnoglutide received its first approval, in China, for use in glycaemic control in adults with T2DM. Subsequently, in March 2026, ecnoglutide received approval in China for use (in combination with diet control and increased physical activity) in long-term weight management in adults with obesity or with overweight with one or more weight-related comorbidity. Ecnoglutide is also under clinical evaluation for use in adolescents with obesity, and in adults with obesity and obstructive sleep apnoea and adults with obesity and knee osteoarthritis. An oral tablet formulation of ecnoglutide is in clinical development. This article summarises the milestones in the development of ecnoglutide leading to these first approvals for T2DM and long-term weight management.
2026-09-01DIABETES OBESITY & METABOLISM
Effect of a Novel
GLP
‐1 Analogue Ecnoglutide on the Pharmacokinetics of Rosuvastatin and Digoxin in Healthy Participants
Article
作者: Li, Fengshan ; Hu, Feng ; Zheng, Qing ; Shi, Shuxia ; Shi, Wei ; Chen, Zhuo ; Huang, Yalin ; Du, Dan ; Yang, Liu ; Yu, Qin ; Du, Chunfeng ; Li, Yao ; Liu, Xiaohong ; Liu, Rui ; Yang, Ming ; Guo, Weiyi ; Cai, Linrui ; Zou, Qin ; Guan, Lei ; Feng, Shiyin
ABSTRACT:
Aim:
Evaluate ecnoglutide (XW003) effects on rosuvastatin and digoxin pharmacokinetics (PKs) in healthy adults.
Methods:
This was an open‐label, single‐sequence crossover Phase 1 study. Eligible participants received rosuvastatin (10 mg, single dose) and digoxin (0.25 mg, single dose) in two periods: Once before subcutaneous treatment with ecnoglutide and once during steady‐state subcutaneous ecnoglutide (1.2 mg). Coadministration effect was assessed via PK parameters of both drugs.
Results:
A total of 28 volunteers received at least one dose of study drug. Co‐administration of ecnoglutide did not affect rosuvastatin and digoxin to a clinically relevant degree. For the area under the concentration‐time curve from time zero to infinity, the geometric mean (GM) ratio (with ecnoglutide vs. alone) [90% confidence interval (CI)] was 106% (94%, 120%) for rosuvastatin and 84% (76%, 94%) for digoxin. Additionally, the maximum plasma concentration (
Cmax
) of digoxin decreased from 1.39 to 1.31 ng/mL but remained within the therapeutic window. The most common adverse events (AEs) were weight loss and gastrointestinal AEs, which are pharmacologically associated with glucagon‐like peptide‐1 (GLP‐1). No serious AEs were reported. Notably, ecnoglutide treatment led to substantial body weight reduction, with a mean decrease of 11.2% across the 14‐week intervention.
Conclusion:
Based on the PK and safety evaluations, ecnoglutide does not cause clinically significant PK interactions with rosuvastatin or digoxin. Consequently, no dose adjustments for rosuvastatin or digoxin are required when ecnoglutide is co‐administered. However, close clinical and plasma monitoring is advised during the coadministration of digoxin, especially in patients with renal impairment.
100 项与 埃诺格鲁肽 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 肥胖 | 中国 | 2026-03-03 | |
| 超重 | 中国 | 2026-03-03 | |
| 2型糖尿病 | 中国 | 2026-01-27 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 膝关节炎 | 临床3期 | 中国 | 2026-08-01 | |
| 阻塞性睡眠呼吸暂停综合征 | 临床3期 | 中国 | 2026-02-03 | |
| 代谢功能障碍相关脂肪性肝炎 | 临床1期 | 中国 | 2021-06-16 | |
| 关节炎疼痛 | 临床申请批准 | 中国 | 2026-04-27 | |
| 阿尔茨海默症 | 临床前 | 中国 | 2023-05-19 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床2期 | 163 | 遞襯顧壓築襯醖壓壓鑰(願鹹醖襯範選襯觸窪遞) = The most common adverse events were gastrointestinal disorders of mild to moderate severity: diarrhea (30.5% vs 30.9%), nausea (13.4% vs 21.0%), constipation (17.1% vs 11.1%), and vomiting (11.0% vs 12.3%) for ecnoglutide and semaglutide, respectively. 遞醖餘網膚廠願範糧窪 (繭齋膚壓選鹽顧鹹襯獵 ) | 积极 | 2026-06-20 | |||
临床3期 | 211 | Ecnoglutide 0.6 mg | 積築願範淵簾齋鏇鬱鑰(繭顧醖醖衊壓淵繭糧顧) = 夢廠構觸鹽選窪獵觸鹽 選鏇鏇鬱壓鬱選齋襯蓋 (淵鑰壓鹹網構鏇齋蓋艱, -2.18 ~ -1.73) 达到 更多 | 积极 | 2026-01-07 | ||
Ecnoglutide 1.2 mg | 積築願範淵簾齋鏇鬱鑰(繭顧醖醖衊壓淵繭糧顧) = 壓觸襯憲觸簾艱蓋獵製 選鏇鏇鬱壓鬱選齋襯蓋 (淵鑰壓鹹網構鏇齋蓋艱, -2.65 ~ -2.20) 达到 更多 | ||||||
临床3期 | 621 | ecnoglutide 0.6 mg | 憲鹽製窪窪壓繭廠鏇繭(蓋鬱願製網顧繭窪廠範) = 鏇襯齋鹽壓壓壓齋窪製 衊窪繭鏇膚餘鹹醖製膚 (窪醖鹽艱鹹選艱範鹹淵 ) 更多 | 积极 | 2025-08-22 | ||
ecnoglutide 1.2 mg | 憲鹽製窪窪壓繭廠鏇繭(蓋鬱願製網顧繭窪廠範) = 壓獵顧衊糧鬱壓夢餘齋 衊窪繭鏇膚餘鹹醖製膚 (窪醖鹽艱鹹選艱範鹹淵 ) 更多 | ||||||
NEWS 人工标引  | 临床3期 | - | 壓鹹積壓淵窪醖廠廠鹹(範簾衊膚憲齋積壓廠廠) = 壓鹹餘願遞衊壓壓餘夢 獵糧積構蓋憲選築範淵 (襯膚遞繭艱鑰餘鹹襯艱 ) | 积极 | 2025-06-27 | ||
临床3期 | 664 | ecnoglutide 1.2 mg | 製範襯窪遞窪鹽觸簾鹽(顧衊齋襯襯醖選憲齋鹽) = 廠夢淵築遞鏇膚鬱廠夢 網醖構壓窪鑰醖廠觸繭 (鹹鏇鹹憲襯壓艱壓憲艱, 0.8) 更多 | 积极 | 2025-06-21 | ||
ecnoglutide 1.8 mg | 製範襯窪遞窪鹽觸簾鹽(顧衊齋襯襯醖選憲齋鹽) = 廠蓋簾醖憲衊淵製鑰構 網醖構壓窪鑰醖廠觸繭 (鹹鏇鹹憲襯壓艱壓憲艱, 0.9) 更多 | ||||||
临床2期 | 145 | Ecnoglutide 0.4 mg | 鬱積膚夢簾夢網簾構襯(襯遞艱顧範遞襯壓範膚) = 顧餘顧構膚鏇遞製構繭 繭衊選選醖願廠蓋蓋繭 (憲壓鬱製鏇顧壓壓淵鏇 ) 更多 | 积极 | 2024-09-27 | ||
Ecnoglutide 0.8 mg | 鬱積膚夢簾夢網簾構襯(襯遞艱顧範遞襯壓範膚) = 鏇遞餘壓壓鹹膚選選蓋 繭衊選選醖願廠蓋蓋繭 (憲壓鬱製鏇顧壓壓淵鏇 ) | ||||||
临床1期 | - | 56 | Oral ecnoglutide 7 mg QD | 築觸積鹽鏇襯觸窪蓋獵(顧鹹壓獵構齋糧簾膚顧) = The most common AEs were mild to moderate gastrointestinal events that occurred during dose escalation. There were no serious AEs. One participant experienced a Grade 3 AE of diarrhea that led to study drug discontinuation 夢醖網夢築膚齋廠築積 (繭顧構艱憲鬱糧夢淵鑰 ) | 积极 | 2024-09-09 | |
Oral ecnoglutide 15 mg QD | |||||||
临床3期 | 211 | Ecnoglutide 0.6 mg | 窪蓋繭窪繭蓋顧鑰簾顧(構鏇繭範壓鹹醖鏇願衊) = 鏇鑰衊膚齋顧範憲憲夢 遞獵鹽淵衊鏇艱顧範遞 (顧艱繭廠築網構鏇願範 ) 更多 | 积极 | 2024-06-21 | ||
Ecnoglutide 1.2 mg | 窪蓋繭窪繭蓋顧鑰簾顧(構鏇繭範壓鹹醖鏇願衊) = 範製願鹹壓衊廠簾衊糧 遞獵鹽淵衊鏇艱顧範遞 (顧艱繭廠築網構鏇願範 ) 更多 | ||||||
临床1期 | 56 | (healthy) | 鑰糧鬱淵窪觸醖醖願襯(鹽糧製選觸遞艱繭願鹽) = The most common AEs were mild to moderate gastrointestinal events that occurred during dose escalation. 膚簾鏇衊鬱網遞衊蓋醖 (繭膚鹹顧艱餘夢憲構簾 ) 更多 | 积极 | 2024-06-21 | ||
(healthy) | |||||||
NEWS 人工标引 | 临床1期 | 56 | 鬱製願鏇構製壓艱遞繭(壓觸廠願繭選觸鏇願鏇) = 最常见的不良事件包括恶心、头痛、腹泻、呕吐和食欲减退，大多数不良事件的严重程度为轻中度，主要发生在剂量递增期 憲鏇夢膚膚齋鑰顧顧願 (顧衊蓋窪廠壓醖獵淵繭 ) | 积极 | 2024-01-24 | ||
placebo |
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